FDA 483 - Mid-Continent Packaging, Inc - March 07, 2022

An FDA inspection of Mid-Continent Packaging, Inc. in Enid, OK, an OTC drug manufacturer, revealed a significant quality control issue. The firm failed to determine actual and theoretical yield percentages at the conclusion of each manufacturing phase, instead performing these calculations months after product distribution. This practice led to delayed identification of significant yield discrepancies, indicating a breakdown in process control and record-keeping.